Method and Device for Collecting and Analyzing Exhaled Breath

ABSTRACT

A method and device for collecting, storing, shipping, preparing and analyzing condensate derived from the exhaled breath of a user. Using the mouthpiece ( 15 ) of the device ( 10 ), a human subject inhales drawing air through a check valve ( 30 ).

TECHNICAL FIELD

The subject invention relates generally to a method and device fordetermining medical conditions, and, more particularly to a method anddevice for condensing, storing, transporting, degassing and analyzingexhaled breath.

BACKGROUND OF THE INVENTION

Recent medical research indicates that human airway acidity and ammonialevels may be indicative of several events including the onset ofasthmatic symptoms. Furthermore, this research indicates that theacidity measurements taken from a condensed sample of exhaled breath canbe correlated to the actual conditions inside the airway.

Many known devices for collecting condensate from a user's breath relyon gravity to form a condensate pool from which a sample for testing maybe drawn. These types of devices require that condensate droplets becomelarge enough to overcome water's naturally tendency to stick to thewalls of a collecting tube. Then, when the amount of condensateeventually becomes large enough, a risk of loss of collected condensatesample through seepage out of the collection area may arise due toineffective sealing of the collection area. Even when an adequatecondensate sample had been collected, a risk of contamination occurreddue to the necessity to transfer the sample from a collecting tube intotest tubes or test devices. Moreover, where the collecting tube is notcooled in some way, condensate formation takes an inordinate amount oftime. In some cases, the collecting tube is inserted into an ice bucketor may even be separately cooled by refrigeration systems in order toincrease the amount and speed of condensate formation. In other cases,use of a Teflon® collecting tube has been tried to make the tube wallsmore slippery to enhance the speed and amount of condensate collected.All of these arrangements tend to be either expensive, complicated,ineffective, bulky, inefficient or time-consuming to use. In addition,other condensate collecting and testing devices generally do not providethe ability in a single device both to quickly and efficiently collectcondensate while also delivering test substances such as gases orliquids into the condensate without contamination. Moreover, suchdevices are not typically portable and do not lend themselves easily touse by patients in their own homes. Another disadvantage of devices ofthe prior art is that they usually do not enable patients to collectcondensate samples, prepare those collected samples for testing and thenalso perform certain tests themselves on the samples.

What is needed is a device and method for condensate collection whichsolves the problems and shortcoming already described and, in addition,collects a greater amount of condensate from a given amount of exhaledbreath in a shorter time than previously possible while also advancingthe art by providing a multi-functional valve for use in such acondensate collection device that simultaneously assists in solvingseveral of those problems.

SUMMARY OF THE INVENTION

The present invention relates to a device and method for collectingcondensate from air exhaled by a subject user. The device comprises amouthpiece, a filter housing, a hollow condensate collecting tube, amovable valve inserted within the collecting tube, a cooling sleeve forplacement over the collecting tube, means for moving the valve throughthe collecting tube and a removable airtight cap. In order to practicethe method employing the device, the cooling sleeve is cooled to atemperature lower than that of the collecting tube prior to being slidthereover, air is inhaled by a subject user through the mouthpiece andexhaled through the movable valve into the collecting tube. After thepassage of between about two and twenty minutes of breathing, thecooling sleeve is removed from around the collecting tube, the movablevalve is advanced through the tube thereby wiping away condensate formedon the interior walls of the tube causing that condensate to collect ina pool around the valve. Thereafter, an airtight cap may be placed overthe end of the collecting tube nearest the condensate pool in order toseal the collecting tube prior to storage and/or shipment to a testinglocation. At the test location, the airtight cap is removed and one ormore gasses or liquids is introduced into the condensate through theunique structure of the valve as called for by the particular test to beperformed on the condensate. In one embodiment of the device, gas isintroduced into the condensate in order to remove carbon dioxide andpermit the acidity level of the condensate to be reproducibly measured.Testing may be performed after removing samples of the condensate fromthe collecting tube or by means of a probe placed into contact with thecondensate pool or by insertion of chemicals or chemically impregnatedstrips.

It is a primary objective of this invention to provide a simpleself-contained and portable device for efficiently collecting, storingand shipping condensate derived from the exhaled breath of a subjectwherein the wettable components of such a device may be disposable.

An additional objective of this invention is to provide a method forcollecting condensate derived from the exhaled breath of a subject whichis fast, simple, efficient and performable by nonprofessional personnel.

A further objective of this invention is to provide a device and methodin which condensate samples collected from the exhaled breath of a usermay be both collected and subjected in situ to various laboratory tests,including ones for measuring pH levels, without the risk ofcontamination by exposure to influences external to a collecting tube.

A yet additional objective of this invention is to provide a condensatecollecting device which may be made available for use in a patient'shome or workplace.

It is still another objective of this invention to provide a device andmultiple methods for removing carbon dioxide from condensate collectedfrom the exhaled breath of a subject preparatory to measuring theacidity of such condensate.

It is yet a further objective of this invention to provide amultipurpose valve structure having a unique elliptical shape for usewithin a tube for collecting condensate from the exhaled breath of asubject which makes the collection of condensate more efficient and alsoassists in preparing the collected condensate for laboratory testing.

It is another objective of this invention to provide a device fordegassing and/or for adding one or more gasses, liquids or othermaterials to a sample of condensate collected from the exhaled breath ofa subject prior to or while performing laboratory tests on that sample.

A further objective of this invention is to provide a device in whichcondensate may be collected, stored and transported in a single unit.

Still another objective of this invention is to provide a condensatecollecting device which makes septuple use of a valve within the devicefor preventing the admission of air from a condensate collecting tubeduring inhalation, admitting exhaled air into the condensate collectingtube, making airflow turbulent, swiping condensate off the interiorwalls of the tube, preventing efflux of condensate, retaining thecondensate in a pool within the tube and channeling gasses or liquidsinto the condensate.

Yet another objective of this invention is to provide a simple andefficient method for deaerating or degassing collected condensate.

Still a further objective of this invention is to provide a malleableduckbill valve having an elliptical cross-section for placement within anon-malleable tube having a circular cross-section so that a seal ismade in the duckbill valve without a pressure gradient across the valve.

A yet additional objective of this invention is to provide a one-waymalleable duckbill valve for placement within a condensate collectingtube which encourages turbulent airflow as a subject's exhaled breathpasses through.

Another objective of this invention is to provide a hollow duckbillvalve permitting a mechanical seal to be obtained between the valve andthe nose portion of a probe inserted into the hollow center of thevalve.

Yet a further objective of this invention is to provide a hollowduckbill valve incorporating one or more passageways through whichgasses or fluids will flow when the valve is subjected to particularmechanical stresses.

An additional objective of this invention is to provide a device withbuilt-in protection for passersby against possible release into theatmosphere of microbes from the lungs of the user of the device.

These and other objects, features and characteristics of the presentinvention, as well as the methods of operation and functions of therelated elements of structure and the combination of parts and economiesof manufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a center cross-sectional view of the device of the invention;

FIG. 2 is a center cross-sectional view of the individual components ofthe device of the invention in a disassembled state;

FIG. 3 is a center cross-section view of the duckbill valve of thisinvention before insertion into a collecting tube along a planeperpendicular to the walls of a collecting tube;

FIG. 4 is a center cross-sectional view of the duckbill valve of thisinvention along line A-A of FIG. 3;

FIG. 5 is a side view of the duckbill valve of this invention;

FIG. 6 is a center cross-sectional view of a collecting tube into whicha probe has been inserted behind a duckbill valve.

FIG. 7 is a center cross-sectional view of a collecting tube into whichgas has been introduced under pressure to degas/deaerate condensate;

FIG. 8 is a schematic of equipment used in performing a second method ofdegassing/deaerating.

DETAILED DESCRIPTION OF THE INVENTION

The device of the invention is intended to be used to condense the waternormally exhaled in breath by a human subject and to gather this waterin such a manner and in such volume that tests may be performed on thecondensate. These tests include measuring acidity, ammoniaconcentration, as well as the concentration of other characteristics,chemicals and compounds of biologic interest. It may be used by anunskilled layperson, then sealed for transport to a laboratory wheresubsequent analysis may be performed. Alternatively, the device may alsofunction as part of a home- or workplace-diagnostic device constructedto accept the device and perform the required measurementsautomatically. Additionally, it may be used in any setting withoutadditional devices, by adding chemical reagents or test strips to detectchemical features and compounds of interest.

For a better understanding of the invention, reference is now made toFIG. 1 of the drawings. This figure illustrates a center cross-sectionalview of invention device 10 in a dormant state prior to use. Device 10may be assembled manually from several principal components eitherbefore use or on site. Mouthpiece 15 may be a generally tubular T-shapeddevice with three open projections. On one end, mouthpiece 15 has agenerally oblong projection 20 designed to be comfortably insertedbetween a subject user's lips. The opposite end projection 25 may begenerally tubular in shape, is open to the atmosphere and includes acheck valve 30 situated nearby for admitting ambient air from theatmosphere through projection 25 into a subject user's mouth and lungsand for preventing an outflow of air through projection 25 during theexhalation process.

Projection 35 is sized so as to be removably insertable into one end ofoptional filter housing 40 and to be retained therein by virtue offriction between the walls of the exterior of projection 35 and thewalls of the interior of the end of filter housing 40 into which it isinserted. Alternatively, projection 35 can be placed in direct intimatecontact with the inner or outer surface of collecting tube 60, andretained there by virtue of friction. During exhalation by the subjectuser, check valve 30 closes and forces exhaled breath to flow throughprojection 35.

Optional filter housing 40 may comprise a tube-like structure open onboth ends and having a filter compartment disposed in the approximatemiddle thereof separating the two openings 45 and 50 of the tube.Opening 45 on one end of filter housing 40 is sized so as to receiveprojection 35 from mouthpiece 15. Optional filter housing 40 includes anoptional filter assembly 55. In the preferred embodiment, the filtercompartment and filter are circular and have a diameter of approximatelyfour times the diameter of opening 50, although other configurations andrelative dimensions may be used. Different pore size of the filter mightbe chosen to limit passage of particles to sizes of particular interest.As particle size might relate to site of formation or other featuresrelevant to the airway, this optional filtering is a useful feature.Optional filter assembly 55 in general functions to remove largerparticles from exhaled breath prior to its entering collecting tube 60and, depending on the filter chosen, also serves to prevent egress ofinfectious particles in the atmosphere during exhalation. This featureprotects passersby from microbes possibly release from the lung of asubject during use of the device. The structure of mouthpiece 15 servesa similar function by substantially reducing the number of salivarydroplets which enter optional filter housing 40 or collecting tube 60.

Collecting tube 60 is a straight plastic tube open on both ends with acircular cross-section and may have a length of between approximately 3inches and 20 inches, preferably about 8.75 inches, and a diameter ofapproximately ½ inch and at most approximately 2 inches, preferablyabout 0.875 inches. With tubes smaller than ½ inch in diameter, exhalingbecomes difficult for the subject user, while with tubes larger than 2inches in diameter, condensation efficiency is low. Regardless of theexact dimension used, the diameter of collecting tube 60 may be slightlysmaller than that of opening 50 in filter housing 40, or alternativelysmaller than that of projection 35, so as to fit retentively within thecorresponding neck of filter housing 40 encompassing opening 50 orwithin projection 35. Alternatively, the diameter of collecting tube 60may be slightly larger than that of opening 50, or projection 35, sothat the neck of filter housing 40 including opening 50, oralternatively projection 35, may be securely and retentively insertedinside one end of collecting tube 60. Collecting tube 60 may also beconstructed from other materials such as stainless steel, anodizedaluminum, Teflon® and various types of plastics, and functions tocollect, condense and store vaporized and aerosolized particles frombreath exhaled thereinto.

The exterior of collecting tube 60 may incorporate a writable surfacefor subject users to identify samples with an indelible marker or othersuitable writing instrument. Alternatively, a label with named fieldsfor information could be used or bar coding or other scannable data withidentifying or destination information could be imprinted on collectingtube 60 prior to delivery.

Duckbill valve 65 is inserted into the lower end of collecting tube 60 adistance of approximately ½ inch and remains in a closed position whenthe device is not in use. Duckbill valve 65 may be comprised of rubberor rubber-like elastomeric materials, or plastics which approximate orbehave as elastomers, and functions to prevent the passage of air fromthe end 75 of collecting tube 60 exposed to the atmosphere during theinhaling process described below using mouthpiece 15 and to admit breathfrom a subject user into collecting tube 60 during the exhaling process,also described below. Its structure and function also prevent thecondensate collected in collecting tube 60 from escaping during andafter the breath condensate collection procedure.

Cooling sleeve 70 is a hollow tube sized to slide over collecting tube60 and place the inner walls of cooling sleeve 70 into physical contactor at least close physical proximity with collecting tube 60 shortlyprior to and during practice of the method of this invention. Coolingsleeve 70 may be slightly shorter than collecting tube 60 and, when inplace, should not extend to a greater height than collecting tube 60.Cooling sleeve 70 may be constructed of a material such as aluminum orany high specific heat, durable, reusable material which does notdeteriorate when wet and tends to retain and maintain a low temperaturewhen cooled. In one preferred embodiment, the cooling sleeve might be acontainer in which chemicals can be mixed that create an endothermicreaction, thus providing substantial cooling.

When placed in position surrounding collecting tube 60 as required forpractice of the method of this invention, cooling sleeve 70 functions todraw heat from the inner surface of collecting tube 60, as will bedescribed below, so as to accelerate the condensing process occurringwithin the tube. In the preferred embodiment, when properly positioned,collecting tube 60 extends on one open end somewhat beyond thecorresponding end of cooling sleeve 70 and terminates approximatelycoequally with the end of cooling sleeve 70 on the other end.Alternatively, collecting tube 60 may extend on the other end beyond thecorresponding end of cooling sleeve 70 so as to be insertable intoopening 50 of optional filter housing 40.

FIG. 2 provides a center cross-sectional view along a center verticalaxis of device 10 of all of the principal components of device 10 in adisassembled state from the component positioned vertically the lowest,mouthpiece 15, to that positioned highest, airtight cap 80. Airtight cap80 is provided as part of device 10 for secure, retentive placement overopen end 75 of collecting tube 60 after the method of the invention hasbeen practiced but prior to storage and/or shipment of collecting tube60 to a laboratory for analysis of condensate. Together with normallyclosed duckbill valve 65, airtight cap 80 seals the condensate samplewithin collecting tube 60 and prevents any fluid exchange with matter orair outside of collecting tube 60. Airtight cap 80 may be formed frommalleable plastic or another material, but its composition is notcritical to practice of the invention so long as it provides a secureseal with open end 75 when placed thereover. Collecting tube 60,duckbill valve 65 and airtight cap 80 together form a disposableassembly which may be prepackaged for a single use ensuring nocomplicated cleaning or contamination issues arise from use of device10.

Duckbill valve 65 is a critical component of device 10. It is uniformlyconstructed from rubber or a material with resilient, rubber-likeproperties. FIG. 3 represents a cross-sectional view of duckbill valve65 taken below valve leaves 100, shown in FIGS. 4 and 5 below, prior toits insertion into collecting tube 60 along a plane perpendicular to thewalls of collecting tube 60 were duckbill valve 65 inserted therein.Note that since collecting tube 60 has a circular cross-section, asindicated by dotted line 85, one would normally expect duckbill valve 65to have a correspondingly circular cross-section. However, itscross-section is uniquely elliptical so that, when forced into acircular shape, such as in the circular bore of collecting tube 60, itwill deform disproportionately so as to create a complete seal betweenthe valve leaves 100 of duckbill valve 65, shown in FIGS. 4 and 5 below.This structure provides a seal even at zero reverse differentialpressure and is dissimilar from duckbill valves known in the art thatrequire pressure gradients to assure complete valve closure. Thisfeature is particularly valuable in this invention since it assists inproviding a secure and long-lasting seal to keep condensate insidecollecting tube 60 during long-term storage and/or transport.

FIG. 4 additionally shows a center cross-sectional view of duckbillvalve 65 across the center of both leaves 100 of the valve on a planeparallel to the walls of collecting tube 60 along line A-A of FIG. 3.Leaves 100 incorporate malleable structures 105 with which they areattached to section 115 of the body of duckbill valve 65. An opening maybe formed along the slit where leaves 100 meet each other. The center ofduckbill valve 65 is hollow. Due to the elliptical valve shapeconstrained in a circular structure, leaves 100 are biased to a closedposition along malleable structures 105. Thus, when a subject user isinhaling, leaves 100 prevent the admission of air into mouthpiece 15through collecting tube 60. However, during exhaling, leaves 100 openalong the slit where they meet and admit air into collecting tube 60.The structure of duckbill valve 65 also results in the creation ofturbulence during exhalation which helps to improve condensationefficiency along the walls of collecting tube 60. For example, shallowbreathing through an empty collecting tube 60 is not very turbulent. Butwhen shallow breathing is directed through duckbill valve 65, leaves 100open only a little , and leaves 100 vibrate, proving that there isturbulent airflow. When heavier breathing at a higher velocity occurs,leaves 100 open further, preventing increased resistance from occurringwhile still encouraging turbulence.

During exhalation, particles of airway lining fluid are ripped off theairway wall and carried in the humid airstream out of the body. When theambient temperature declines below the dew point (i.e. upon egress fromthe mouth), the gas phase water vapor/water molecules attach themselvesonto the small aerosolized particles, enlarging the particles andincreasing the chance by inertia that they will strike nearby surfacessuch as the interior walls of collecting tube 60, especially where thereis turbulent airflow. Thus, the creation of turbulent airflow byduckbill valve 65 is another important feature since it allows fluidparticles to impact the inner surface of collecting tube 60, encouragingfluid collection.

Duckbill valve 65 incorporates a notched area around its exterior intowhich is tightly and sealingly fitted a rubberized Teflon® ring 110having an exterior diameter just slightly greater than that of the minoraxis of the ellipse formed by the footprint of duckbill valve 65 when atrest. Therefore, when ring 110 is in place, it is biased and makessealing contact with the interior walls of collecting tube 60. Ring 110may also be composed of materials other than Teflon® such aspolypropylene, so long as it functions in the same way as does theTeflon® ring described. This ring serves three functions. First, it is awiper which, as discussed below, removes condensation from the interiorwalls of collecting tube 60 after the subject user has completedexhalation. Second, it maintains the alignment of duckbill valve 65 inan orthogonal orientation to the walls of collecting tube 60. Finally,it functions as a valve itself as discussed next.

The lower part of duckbill valve 65 consists of two general sections 115and 120. There are one or more hollow passageways 125 running diagonallyupward from an initiation point 130 within the interior hollow area ofduckbill valve 65 through lower section 120 into the circular notchedarea formed on the exterior of duckbill valve 65. Note that only onepassageway 125 is required for subsequent degassification or deaerationsteps, although as many as ten such passageways may be preferreddepending on the circumstances. Also, note that such passages are notcircumferential around the valve, so that in a slightly different crosssection, they would not be seen at all, revealing that upper section 115is confluent with lower section 120 throughout most of the valvestructure.

Lower section 120 tends to be stiffer than upper section 115 since thereis a greater volume of material in lower section 120 and, unlike section115, it is constrained from movement by direct contact with the walls ofcollecting tube 60. Thus, when gas pressure is introduced throughpassageways 125 against Teflon® ring 110, section 115 has a tendency todeflect allowing the gas to pass around Teflon® ring 110 and into theportion of collecting tube 60 above duckbill valve 65. First inner ring135 is a bump-like ridge extending around the hollow inner portion ofduckbill valve 65 at approximately at its base. Second inner ring 140 isanother bump-like ridge extending around the hollow inner portion ofduckbill valve 65 at a point displaced slightly above initiation point130 of any passageway 125. The importance of these features will becomeclear in conjunction with discussion of the degassing of collecting tube60 discussed below in conjunction with FIGS. 6 and 7.

FIG. 5 shows a side view of duckbill valve 65 along a plane rotated 90degrees around a vertical axis from the view shown in FIG. 4. Thisrepresents a side view along the plane represented by the line B-B ofFIG. 3. As is evident, the valve has a bilateral structural symmetry.

The method of this invention is practiced after device 10 has beenassembled as described above and shown in the drawings. Although not arequired assembly step, cooling sleeve 70 may be placed in a freezer forapproximately 20 to 30 minutes prior to use since the larger thedifference in temperature between the walls of cooling sleeve 70 andcollecting tube 60 the faster and more efficiently condensation willoccur and the greater the amount of condensate produced will be. It isrequired, however, that cooling sleeve 70 be somewhat cooler thancollecting tube 60 prior to beginning to practice the method so that thecondensation process will be enhanced. The cooling sleeve 70 can becooled to various temperatures depending on need. When chilled to −20degrees C. or below, for example, the exhaled fluid and vapors collectas frozen solid material on the inside of the collecting tube 60, afeature advantageous for the assays of compounds unstable in liquidphase water, as would be the case with a cooling sleeve chilled to asomewhat higher temperature. Temperatures obtained in a homerefrigerator or home freezer are satisfactory for excellent liquid phasefluid collection for most purposes, including assessing pH. Throughoutpractice of the method until after installation of airtight cap 80, itis preferable to keep collecting tube 60 reasonably perpendicular to theground.

As the first step in the method, referring again for visual reference toFIG. 1, a subject user places projection 20 of mouth piece 15 betweenhis or her lips and inhales. Duckbill valve 65 remains closed due to thebias of flaps 100 and air is admitted into mouthpiece 15 from projection25 through check valve 30. The subject user then exhales. The stream ofexhaled breath is blocked from egress out of projection 25 by checkvalve 30 and follows the path of least resistance upward throughprojection 35 into optional filter housing 40, through optional filterassembly 55 and into duckbill valve 65 where leaves 100 are caused toseparate and open due to the air pressure allowing the exhaled breath toenter collecting tube 60. When exhalation is complete, leaves 100 returnto their naturally biased closed position.

Due to the temperature differential between the exhaled breath and theair inside and the walls of collecting tube 60, the temperature of whichhas been lowered due to the contact or close proximity of collectingtube 60 with cooling sleeve 70, condensation begins to form on the wallsof collecting tube 60 as exhaled breath traverses the length ofcollecting tube 60. Due to the force of gravity, some condensate tendsto run down the walls of collecting tube 60 to form a pool aroundTeflon® ring 110 at the base of duckbill valve 65. Most remains in placeas tiny droplets on the inner wall of collecting tube 60. Meanwhile, theremaining, now dehydrated, exhaled breath is allowed to escape from openend 75 of collecting tube 60 which remains open to the atmosphere. Ingeneral, between about two and twenty minutes of breathing will beperformed to provide sufficient sample. In preferred embodiments, a setnumber of breaths, for example ten, will be sufficient.

While keeping collecting tube 60 perpendicular to the ground and the endof collecting tube 60 containing duckbill valve 65 nearest to theground, cooling sleeve 70 is slid away from collecting tube 60. Then,while keeping collecting tube 60 reasonably perpendicular to the groundand the end of collecting tube 60 containing duckbill valve 65 nearestto the ground, optional filter housing 40 and collecting tube 60 aremanually pulled apart and disengaged from each other. Alternatively,projection 35 and collecting tube 60 are manually pulled apart, if thefilter is not employed.

A piston and rod combination is provided as an accessory to device 10.The piston is designed to fit within collecting tube 60 and to be placedinto uniform flat contact with the entire bottom surface of duckbillvalve 65 after cooling sleeve 70 and collecting tube 60 are separated.The rod may be attached to the piston in advance or after insertion ofthe piston into collecting tube 60. Pressure is then exerted againstduckbill valve 65 by means of the rod and piston combination movingduckbill valve 65 vertically upwards through the inside of collectingtube 60 towards open end 75 thereof. Due to the wiper action of Teflon®ring 110, tiny drops of condensate clinging to the walls of collectingtube 60 are collected into a small pool building up around and ahead ofTeflon® ring 110. The rod and piston combination are removed fromcollecting tube 60 when duckbill valve 65 has been moved to withinapproximately two inches from open end 75 of collecting tube 60. At thispoint, airtight cap 80 is securely and sealably installed over open end75 so that collecting tube 60 may be stored and/or shipped to anotherlocation, such as a laboratory. By moving duckbill valve 65 towards openend 75, the volume of air within collecting tube 60 is reduced forstorage purposes, and the surface area of the condensate which mightcome into contact with contaminating air is minimized. Alternatively,the movement of duckbill valve 65 within collecting tube 60 can bedeferred until after transport. When desired, this piston and rodcombination may also serve the additional purpose of providing adegassing mechanism, as discussed below.

Once sealed collecting tube 60 has arrived at a testing location, whichmay even be at a subject user's home or workplace if diagnosticequipment is stationed there, the collected condensate may be subjectedto a variety of treatments depending on the assay desired to beundertaken. Where acidity of the condensate is to be tested or ofconcern, a degassing or deaeration of the condensate is performed.Degassing or deaerification is a purification process which removescarbon dioxide from the condensate and allows for more accurate andstable measurement of acidity or pH levels. Without this deaerationstep, the carbon dioxide in air diffuses in and out of the condensate,changing its pH. This can occur simply as the result of a personbreathing over the top of collecting tube 60 when it is open. Thus, anygas that does not contain carbon dioxide or another acid may be used fordegassing prior to pH measurement including, but not limited to, argon,helium, oxygen or air that has had carbon dioxide removed from it with acarbon dioxide trap. Alternatively, elimination of carbon dioxide couldbe accomplished chemically by adding an enzyme and substrate thatconsumes carbon dioxide and a proton (acid) in a one-to-one ratio.

In order to perform degassing on the condensate in sealed collectingtube 60, any one of three methods may be used. First, a probe, which mayalso serve as the piston discussed previously, may be inserted throughthe bottom open end of collecting tube 60 and advanced until its furtherprogress is blocked by contact with duckbill valve 65 whereupon pressureis exerted until the nose portion of the probe is seated within duckbillvalve 65. Airtight cap 80 should then be removed. Reference is now madeto FIG. 6 where a partial cross-sectional view of collecting tube 60 isshown in which probe 200 has been seated within duckbill valve 65. Thenose portion of probe 200 has a diameter slightly wider than thediameter of first inner ring 135. In order to seat probe 200, the noseportion is pushed into the hollow center of duckbill valve 65 untilfurther forward movement is impeded by contact between the widershoulder portion of probe 200 and lower section 120 of duckbill valve65. At this point, first inner ring 135 has been compacted horizontallyso as to form a pressure seal around the nose portion of probe 200 belowpassageway 125, while second inner ring 140 has also been compactedhorizontally to form another pressure seal around the nose portion ofprobe 200 above passageway 125.

Probe 200 includes a hollow, multipath, cylindrical passageway 205including one or more openings 210 which exit the nose portion of probe200 at a height equivalent to the location of initiation point 130within valve 65. Specifically, the location of openings 210 lies betweenfirst inner ring 135 and second inner ring 140 inside valve 65. Argon oranother carbon dioxide-free gas may be introduced under pressure throughpassageways 205 of probe 200. As shown in FIG. 7, the pressurized gasfollows the path indicated by the dotted lines accompanied by arrows.The mechanical pressure seals formed by inner rings 135 and 140 againstthe nose portion of probe 200 are considerably stronger than the sealproduced by ring 110 against the circular notched area formed on theexterior of duckbill valve 65. Due to the positioning of passageway(s)125, they are not subjected to stress and exit duckbill valve 65 at apoint where the valve is not subjected to mechanical stress. As aresult, the pressurized gas introduced through passageways 205 followsthe unstressed portion of duckbill valve 65, or passageways 125.

As explained above, upper section 115 tends to deflect when exposed topressurized gas thereby creating a passageway for the gas to circumventTeflon® ring 110 and escape into and bubble through condensate 215pooled in collecting tube 60. Carbon dioxide dissolved in condensatediffuses into the bubbles of the carbon dioxide-free gas. After havingpassed through condensate 215, the gas, now containing carbon dioxidederived from the condensate is allowed to escape into the atmospherefrom collecting tube 60 through now uncapped open end 75. Argon, beingheavier than air, assists in preventing carbon dioxide from the ambientair from recontaminating the sample.

An alternative structure for duckbill valve 65 could omit ring 110 andhollow passageways 125 and probe 200. In this case, gas pressure appliedinto collecting tube 60 below valve 65 by a positive pressure manifoldwould cause leaves 100 in duckbill valve 65 to open admitting the gasinto the condensate pool. The pressure of the gas would preventcondensate from seeping back into the open valve as would the closingbias of leaves 100 when the application of gas pressure terminated. Oneexample of such a manifold would accept the lower end of collecting tube60, make an airtight seal with it and hold it in a vertical positionwhile forcing gas into the tube for degassing. The manifold couldinterface with available gas plumbing or hoses connecting to a source ofgas.

The third method for degassing is shown in schematic form in FIG. 8.Pursuant to that method, airtight cap 80 is removed from collecting tube60 which is then inserted into a device enclosing both ends of the tube.A hard vacuum is applied to both ends of the tube and the area of thetube below the duckbill valve is periodically opened to the atmosphereor to a carbon dioxide-free gas source. This procedure draws the carbondioxide out of the solution in the condensate and allows it to beremoved through the vacuum pump. Open end 75 of collecting tube 60 isplaced in manifold 300, while the opposing end of the tube is placed inmanifold 305. Vacuum pump 310 is attached to open end 75 by means ofmanifold 300, while vacuum gauge 315 is attached to the opposing end ofcollecting tube 60 by means of manifold 305. Three-way, two-positionsolenoid valve 320 is connected between vacuum pump 310 and vacuum gauge315. An adjustable orifice 325 functioning with solenoid valve 320 isused to regulate the surge of air or other gas into the lower chamber ofcollecting tube 60, and a filter 330 is connected to adjustable orifice325 in order to ensure that no contaminants are introduced into thesystem. A human may be used to determine when to vent the lower part ofcollecting tube 60 through manifold 305 based on readings from vacuumgauge 315. Alternatively, a vacuum transducer coupled to a controllercould be substituted for the vacuum gauge to automate the venting of thecollecting tube by energizing solenoid valve 320 pursuant to a controlalgorithm.

Certain tests might require passing other gases through or addingliquids or solids to the condensate. The same structures and proceduresdescribed above may be used to collect, transport, store and otherwiseaccomplish these tasks. Other tests that might be performed on collectedsamples include assays for inorganic and organic compounds, includingbut not limited to amino acids, volatile organic compounds, lipids andlipid oxidation products, armmonia, simple ions such as sodium andchloride, strong and weak acids and bases, surfactant, inflammatorymediators including cytokines and leukotrienes, oxidation and nitrationproducts including hydrogen peroxide and nitrotyrosine, nucleic acidssuch as DNA and RNA, endotoxin and other microbial products. Inaddition, it is important to note that the entire cycle of sampling,storage, degassing and much, if not all, of the analysis is done withindevice 10. Transfer of fluid to other apparati is not generallyrequired. Furthermore, all wetted parts of device 10 can easily be madedisposable to minimize contamination, cleaning, and cost. The device isfully portable and can be used even by small children. In an alternativestructure, a filter may be positioned on top of collecting tube 60 toprevent infectious particles from escaping while allowing largerparticles to be trapped in collecting tube 60. Finally, the device andmethod of this invention may be adapted for animal use in veterinarianapplications.

When the collected condensate sample has been prepared for testing asrequired, either by degassing or by addition of gas, liquid or anothersubstance, a probe may be inserted through open end 75 to remove asample of the condensate for testing purposes. Alternatively, thetesting can be performed directly within collecting tube 60. Forexample, after degassing, a calibrated pH probe attached to a pH metercan be immersed in the collected sample to determine sample pH. Thesample may be removed by contact with the probe or by suction actionthrough the probe. In other embodiments, chemicals can be added, or achemically impregnated reagent strip can be immersed into the sample forcolorimetric determination of pH and other characteristics andsubstances.

The foregoing invention has been described in terms of the preferredembodiment. However, it will be apparent to those skilled in the artthat various modifications and variations can be made to the disclosedmethod and system without departing from the scope or spirit of theinvention. The specification and examples are exemplary only, while thetrue scope of the invention is defined by the following claims.

1) A portable device for collecting, sporting, storing and processingcondensate from air exhaled thereinto comprising: a mouthpiece havingthree projections by means of which air is inhaled and exhaled; anoptional filter housing having two openings separated by a filterassembly the first one of which is interconnected with a firstprojection of said mouthpiece; a hollow condensate collecting tubehaving two open ends and a circular cross-section interconnected at afirst open end with the second opening of said filter housing; movablevalve means deformable and sealingly inserted between the interior wallsof said collecting tube near the first open end thereof for preventingthe admission of air during inhalation; admitting exhaled air into saidcollecting tube, making airflow therethrough turbulent, swipingcondensate off the interior walls of said collecting tube, preventingefflux of condensate, retaining the condensate in a pool and channelinggasses or liquids into the condensate; hollow removable cooling sleevemeans slidably placed over said collecting tube wherein said coolingsleeve means has an interior diameter only slightly greater than theexterior diameter of said collecting tube so that the interior walls ofsaid cooling sleeve means are in at least close physical proximity tothe exterior walls of said collecting tube for drawing heat from theinner surface of said collecting tube to accelerate the condensingprocess; and advancement means removably insertable into the first openend of said collecting tube behind said valve means for pushing saidvalve means upwards towards the second open end of said collecting tube.2) The device of claim 1 wherein carbon dioxide is removed from thecondensate preparatory to testing the acidity level of the condensate bychanneling one or more gases through said valve means into thecondensate. 3) The device of claim 2 wherein the gas channeled throughsaid valve means is one or more selected from argon, helium, oxygen orair that has had carbon dioxide removed from it with a carbon dioxidetrap. 4) The device of claim 1 further including airtight cap means forproviding a removable seal over the second open end of said condensatecollecting tube after removal of said advancement means from saidcollecting tube prior to storage and/or shipment to another location. 5)The device of claim 1 wherein a second projection of said mouthpieceincludes check valve means for admitting air during inhalation andinhibiting the egress of air during exhalation 6) The device of claim 1wherein said valve means has valve leaves and a generally ellipticalcross-section which is deformed into a circular shape upon insertioninto said collecting tube. 7) The device of claim 6 wherein by deformingsaid valve means a complete seal is created between the valve leaves. 8)The device of claim 7 wherein said valve means is generally hollow andincludes an upper section of lesser mass and a lower section of greatermass and wherein the boundary between the upper and lower sections isgenerally defined and separated by one or more pairs of hollowpassageways formed in the body of said valve means each of whichpassageways extends from near the bottom of the hollow interior of saidvalve means diagonally upward to the exterior of said valve meansexiting into a generally semi-circular notch formed at a point above thebottom of said valve means displaced between approximately one-eighthand one-quarter of the length of said valve means away from the bottomthereof 9) The device of claim 8 wherein resilient ring means are seatedin the notch in said valve means for maintaining said valve means in anorthogonal orientation with the interior walls of said collecting tube,for wiping the inner walls of said collecting tube as said valve meansis pushed upwardly therethrough and for deflecting in reaction to forceexerted upon it by a pressurized substance flowing through the hollowpassageways within said valve means. 10) The device of claim 1 whereinsaid cooling sleeve means has a lower temperature than said collectingtube. 11) The device of claim 10 wherein said cooling sleeve means tendsto maintain a low temperature. 12) The device of claim 11 wherein saidcooling sleeve is comprised of aluminum. 13) The device of claim 11wherein said cooling sleeve is comprised of a material having a highspecific heal 14) The device of claim 1 wherein said cooling sleeve isbetween approximately one-quarter and one-half inch shorter than saidcollecting tube. 15) The device of claim 1 further includingdegassification means for forcing pressurized gas through thecondensate. 16) The device of claim 15 wherein said degassificationmeans is a physical probe which is inserted into the open bottom end ofsaid collecting tube and extended therethrough until brought intophysical contact with the bottom of said valve means. 17) The device ofclaim 15 wherein said degassification means is a single positivelypressurized manifold into which the open bottom end of said collectingtube is retainably inserted and through which said collecting tube ismaintained in a vertical position. 18) The device of claim 15 whereinsaid degassification means comprises a first manifold into which theopen bottom end of said collecting tube is retainably placed and asecond manifold into which the open top end of said collecting tube isretainably placed wherein both ends of said collecting tube aresubjected to a mechanized vacuum and wherein further said secondmanifold is periodically opened to atmospheric pressure. 19) The deviceof claim 1 wherein the structure of said mouthpiece substantiallyreduces the number of salivary droplets which are exhaled by a subjectfrom entering said optional filter housing or said collecting tube.20-27. (canceled)
 28. A device for collecting condensate from breathexhaled thereinto comprising: mouthpiece means for admitting anddirecting both inhaled and exhaled breath; a hollow condensate tubehaving two open ends connected on one end to said mouthpiece means;movable valve means sealingly inserted between the interior walls ofsaid tube for preventing the admission of air during inhalation,controlling the admission of exhaled breath into said tube duringexhalation and swiping condensate off the interior walls of said tube asit is moved along said tube.
 29. The device of claim 28 wherein saidvalve means further makes airflow through said tube turbulent, preventsefflux of condensate, retains condensate in a pool and channels gassesor liquids into the condensate.
 30. The device of claim 28 furthercomprising cooling means for cooling said tube and for accelerating theformation of condensate.
 31. The device of claim 30 wherein said coolingmeans further comprises a pre-chilled hollow, tubular sleeve placed inclose physical proximity to the exterior walls of said tube.
 32. Thedevice of claim 31 wherein said cooling means is constructed fromaluminum or any high specific heat, durable, reusable material whichdoes not deteriorate when wet and tends to retain and maintain a lowtemperature when cooled.
 33. The device of claim 31 wherein said coolingmeans is a container in which chemicals can be mixed that create anendothermic reaction.
 34. The device of claim 28 further comprisingadvancement means for causing said valve means to move from one end ofsaid tube to the other.
 35. The device of claim 34 wherein saidadvancement means is a rod and piston arrangement.
 36. The device ofclaim 28 wherein said tube is constructed from one or more of the groupof materials consisting of plastic, stainless steel, anodized aluminum,and Teflon®.
 37. The device of claim 28 wherein said valve means isconstructed from one or more of the group of materials consisting ofrubber, rubber-like elastomeric materials, and plastics which behave aselastomers.
 38. The device of claim 28 wherein the device is disposable.